MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07K65-34

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.

Event Description

The customer observed falsely elevated architect free t4 results on a patient diagnosed with hypothyroidism.The following data was provided: on (b)(6) 2023.Tsh 1.65, ft3 2.41, ft4 1.42.Sid (b)(6) , on (b)(6) 2024 , initial test, repeat test, tsh 2.8109 uiu/ml, 3.5787 uiu/ml, ft3 2.84 pg/ml, 2.33 pg/ml, ft4 >5.00 ng/dl, 1.95 ng/dl.Sid (b)(6), on (b)(6) 2024, initial test, repeat test, ft4 >5.00 ng/dl, 0.96 ng/dl.Sid (b)(6), on (b)(6) 2024, initial test, repeat test, ft4 2.05 ng/dl, 1.18 ng/dl.No impact to patient management was reported.

Manufacturer Narrative

Data and information provided by the customer were reviewed and align with the complaint issue and no additional issues were identified.The ticket search by lot indicates that the reagent lot shows elevated complaint activity, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any non-conformances or deviations with the complaint list number.A review of ticket trending did not identify any related trend regarding commonalities for complaint lot number and issue.Retained analysis of architect free t4 reagent lot 56001ud00 was performed.Testing met acceptance criteria and the product is performing as expected.A review of the labelling addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.

• Brand Name: ARCHITECT FREE T4 REAGENT KIT
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18917399
• MDR Text Key: 337858709
• Report Number: 3005094123-2024-00126
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: 00380740119805
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Catalogue Number: 07K65-34
• Device Lot Number: 56001UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR55690; ARC I2K PROC MOD, 03M74-01, ISR55690